- Implement the Data Integrity culture and CSV strategies for site Tech at Lilly ensuring compliance with global and local regulatory requirements for systems used at the site (both local and global).
- Coordinate the technical evaluation with site Tech at Lilly subject matter experts (SMEs) of new and existing systems from a Data Integrity and CSV perspective.
- Provide CSV consulting and assist with articulation of CSV needs to the CSV third party service provider(s).
- Lead the implementation of technology solutions across the site to improve DI /CSV compliance.
- Collaborate internally and externally to establish best practices and evaluate new points of consideration to improve technology use at the site.
- Partner with the Site Data Leader and leadership to lead the gap analysis and remediation efforts of policies associated with DI, LQPs, GQS, SOPs and CSV.
- Represent site in DI/CSV related deviations and CAPAs.
- Provide support in the event of internal, external, and regulatory audits.
- Partner cross-functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new DI/CSV expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand-alone equipment.
- Solves problems while exhibiting judgment.
- Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only.
- Proficiency with CSV and demonstrated ability to right-size validation based upon risk.
- Solid knowledge of Computer System Validation process and Data Integrity.
- Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
- Strong analytical and problem-solving skills to identify and resolve technical issues related to Labs systems, configurations, or integrations. Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related). Effectively prioritize and escalate issues.
- Adaptability and flexibility to work in a fast-paced environment and manage multiple tasks simultaneously.
- Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
- Minimum of 5+ years of experience working in a regulated industry (i.e., GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution.
- Master's degree in Software Engineering, Computer Science, Computer Engineering, or a related field.
- Build solutions using an agile framework for the entire solution lifecycle including designing, implementing, automating, modernizing, maintaining, and optimizing solutions.
- Experience with technical mentoring and developing technical team members.
- Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
- Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
- Position will be based out of the Concord, NC site with ability to travel to Indianapolis and other global Lilly sites as required.
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Manager-CSV Lead - Concord, United States - BioSpace
Description
Job DetailsAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Brand Description:
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 38,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for individuals who are determined to make life better for people around the world.
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss
What You'll Be Doing:
You will be part of Tech at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Tech at Lilly MQ strives to enable the making of medicine "with safety first and quality always".
As CSV Lead, you will partner with the Site Data Leader and Site Tech at Lilly leadership to implement the computer system validation (CSV) and Data integrity strategies and culture for Site Tech at Lilly. This role will leverage a deep understanding of CSV and Data Integrity principles ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global Tech at Lilly systems used at the Concord site. This role will collaborate with the local and global CSQA and Tech at Lilly organizations to enable best practices, processes, and governance and to consider new points to strengthen the Tech at Lilly CSV and Data Integrity position and align with corporate objectives and initiatives.
How You'll Succeed:
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
#WeAreLilly
Manager-CSV Lead professionals in Concord
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Melanie Blaylock
15 year experienced scientific researcher